Drugs@FDA: FDA-Approved Drugs
Abbreviated New Drug Application (ANDA): 206551
Company: ACCORD HLTHCARE
Company: ACCORD HLTHCARE
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | TE Code | RLD | RS |
---|---|---|---|---|---|---|---|
BIVALIRUDIN | BIVALIRUDIN | 250MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | AP | No | No |
Original Approvals or Tentative Approvals
Action Date | Submission | Action Type | Submission Classification | Review Priority; Orphan Status | Letters, Reviews, Labels, Patient Package Insert | Notes | Url |
---|---|---|---|---|---|---|---|
11/22/2017 | ORIG-1 | Approval | STANDARD |
Letter (PDF)
Letter (PDF) |
Label is not available on this site. |
https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206551Orig1s000TAltr.pdf https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2016/206551Orig1s000ltr.pdf |
BIVALIRUDIN
INJECTABLE;INTRAVENOUS; 250MG/VIAL
TE Code = AP
Drug Name | Active Ingredients | Strength | Dosage Form/Route | Marketing Status | RLD | TE Code | Application No. | Company |
---|---|---|---|---|---|---|---|---|
ANGIOMAX | BIVALIRUDIN | 250MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | Yes | AP | 020873 | SANDOZ |
BIVALIRUDIN | BIVALIRUDIN | 250MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 206551 | ACCORD HLTHCARE |
BIVALIRUDIN | BIVALIRUDIN | 250MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 201577 | DR REDDYS |
BIVALIRUDIN | BIVALIRUDIN | 250MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 205962 | EUGIA PHARMA |
BIVALIRUDIN | BIVALIRUDIN | 250MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 090189 | FRESENIUS KABI USA |
BIVALIRUDIN | BIVALIRUDIN | 250MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 090811 | HOSPIRA |
BIVALIRUDIN | BIVALIRUDIN | 250MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 090816 | HOSPIRA |
BIVALIRUDIN | BIVALIRUDIN | 250MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 091602 | MEITHEAL |
BIVALIRUDIN | BIVALIRUDIN | 250MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 202471 | MYLAN INSTITUTIONAL |
BIVALIRUDIN | BIVALIRUDIN | 250MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 210031 | SHUANGCHENG |
BIVALIRUDIN | BIVALIRUDIN | 250MG/VIAL | INJECTABLE;INTRAVENOUS | Prescription | No | AP | 213078 | SLATE RUN PHARMA |